FDA Strengthens Warning That NSAIDs Can Cause MIs or Strokes

The US Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) increase the chance of a myocardial infarction (MI) or stroke.

Based a comprehensive review of new safety information, the FDA is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on MI and stroke risk. The FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels.

Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.

The risk of a MI or stroke with NSAIDs was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, the FDA has reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies, a large combined analysis of clinical trials, and other scientific publications. These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held in February of last year.

Based on the review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information: The risk MI or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID. The risk appears greater at higher doses.

It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for MI or stroke is similar for all NSAIDs; however, this newer information is not sufficient for the FDA to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.

NSAIDs can increase the risk of MI or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.

In general, patients with heart disease or risk factors for it have a greater likelihood of MI or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.

Patients treated with NSAIDs following a first MI were more likely to die in the first year after the MI compared with patients who were not treated with NSAIDs after their first MI.

There is also an increased risk of heart failure with NSAID use.

Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken.